Kornimate/medical-research-clean huggingface dataset:
open-label, extension study of aripiprazole intramuscular depot (opc-14597, lu af41155) in patients with schizophrenia

Conditions: Schizophrenia

Summary: the phase 3 trial 31-12-291 is part of the aripiprazole im depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole im depot for the treatment of adults experiencing an acute relapse of schizophrenia. subjects receive treatment during a 12-week double-blind acute treatment phase. the current trial (31-12-297) will allow the subjects who complete trial 291 to enter this open label trial at the investigator's discretion, where additional safety and tolerability data will be collected.


Eligibility criteria:
inclusion criteria: * male and female subjects 18 to 66 years of age, inclusive, at the time of informed consent. * subjects who are able to provide written informed consent (as required by irb/iec) prior to the initiation of any protocol-required procedures. * ability, in the opinion of the investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales. * subjects who have met the completion criteria in the 31-12-291 registrational trial for the acute treatment of adults with schizophrenia * subjects who, in the investigator's judgment, require chronic treatment with antipsychotic medication and would benefit from extended treatment with an im depot formulation. * outpatient status at the week 12 in trial 291, with the exception of those subjects eligible to enter trial 297 due to a positive interim analysis. exclusion criteria: * sexually active males of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 180 days after the last dose of trial medication. sexually active women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 150 days after the last dose of trial medication. * females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving imp in this trial. * subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that requires treatment with an antidepressant. * subjects who are anticipated needing cyp2d6 or cyp3a4 inhibitors or cyp3a4 inducers during the course of the trial. * subjects with a significant risk of violent behavior; who represent a risk of committing suicide; or who in the clinical judgment of the investigator present a serious risk of suicide. * subjects requiring any antipsychotic(s) other than aripiprazole im depot after completion of trial 291. * subjects likely to require prohibited concomitant therapy during the trial * laboratory test and ecg results which are exclusionary * any subject who, in the opinion of the investigator or medical monitor, should not participate in the trial

Keywords: schizophrenia
a study of ribociclib in combination with hormonal therapy in hr+/her2- advanced or metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a non-interventional, ambispective, observational cohort study describing the real-world safety data of approximately 550 hormone receptor / human epidermal growth factor receptor 2 (hr+/her2-) advanced/metastatic breast cancer patients who have received ribociclib combined with hormonal therapy in pre-and postmenopausal women or men in middle eastern countries.

the investigators will have a six-month recruitment period to include the eligible subjects as per the protocol selection criteria. retrospective patients should have been on ribociclib in combination with hormonal therapy for at least 18 months and stopped the medication before the patient's recruitment. ambispective patients should have initiated ribociclib, in combination with hormonal therapy, for at least 12 months before the patient's recruitment date and are still on ribociclib in combination with hormonal therapy at recruitment. these patients will be followed up till progression, death, ribociclib discontinuation due to adverse events, or till a maximum period of 6 months, whichever comes first. data will be collected from patient electronic medical records in the sites chosen for patients who received ribociclib, in combination with hormonal therapy, in the first or second-line setting available in the relevant institutions. a total of 550 patients is planned for this study. the planned sample size should capture very common adverse events reported in previous studies as well as adverse events ≥ 10% occurring in grade 3 and grade 4 with precision ±2.5%.

Eligibility criteria:
inclusion criteria: 1. adult patients ≥ 18 years old at the time of receiving ribociclib in combination with hormonal therapy. 2. advanced /metastatic breast cancer 3. estrogen-receptor-positive and/or progesterone receptor-positive breast cancer. 4. her2-negative breast cancer. 5. patients who received or currently receiving ribociclib in combination with hormonal therapy in the first or second-line settings as per the routine practice. 6. for the ambispective part, patients should have initiated the ribociclib, in combination with hormonal therapy, line of treatment at least 12 months before the patient's recruitment date and still continuingcontinuing the drug at the baseline visit. 7. for retrospective patients only, the patients should have been on ribocilib, in combination with hormonal therapy, for at least 18 months and stopped ribociclib before the siv date.enrollment 8. for ambispective part, patients agree to sign informed consent before their enrollment. exclusion criteria: 1. ribociclib-based treatment regimen beyond the second line. 2. patients are currently participating in any other clinical trials. 3. patient with a known hypersensitivity to any of the excipients of ribociclib. 4. patients who previously received any other cdk4/6 inhibitor . 5. for ambispective patients, patients who refuse to sign the informed consent

Keywords: hr+/her2- advanced/metastatic breast cancer nis ribociclib middle eastern countries
high-flow nasal cannula oxygen therapy with the chest trauma patients

Conditions: Blunt Thoracic Injury; Lung Ultrasound Score

Summary: this prospective randomized controlled study was conducted in the emergency intensive care units (eicu) of the second affiliated hospital zhejiang university school of medicine, a large tertiary university hospital in hangzhou, china.the aim of this randomized study was to compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in icu patients with blunt thoracic injury.

this prospective randomized controlled study was conducted in the emergency intensive care units (eicu) of the second affiliated hospital zhejiang university school of medicine, a large tertiary university hospital in hangzhou, china.the aim of this randomized study was to compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in icu patients with blunt thoracic injury.

Eligibility criteria:
inclusion criteria: - the trauma registry was used to identify patients with moderate to severe blunt thoracic injury (abbreviated injury scale (ais) chest score ≥3) admitted to the icu exclusion criteria: 1. had intubation and used the mechanical ventilation within 2 hours 2. had the emergency surgerys within 2 hours 3. patients can not accessed by transthoracic lung ultrasound because of the sever aerodermectasia or pneumothorax 4. the glasgow coma scale \<8
medical nutrition therapy for medically complex infants in the pediatric outpatient setting

Conditions: Growth Failure in Medically Complex Infants; Growth Failure; Malnutrition in Medically Complex Infants; Malnutrition; Nutrition in Medically Complex Infants; Nutrition; Nutrition Disorder, Infant

Summary: the purpose of this study is to compare standardized nutrition therapy provided by a registered dietitian (rd) at regularly scheduled intervals to usual care in terms of the ability to improve growth parameters in medically complex infants in the pediatric outpatient setting.


Eligibility criteria:
inclusion criteria: * patients who are admitted between july, 2018 and june, 2019 to the neonatal high-risk clinic (nhrc) and high risk children's clinic (hrcc) at ut health from a neonatal intensive care unit (nicu) exclusion criteria: * short bowel syndrome, * requiring parenteral nutrition (pn) * active cancer
platelets to lymphocytes ratio and monocytes to lymphocytes ratio as predictors of response to treatment in cirrhotic patients with spontaneous bacterial peritonitis.

Conditions: Cirrhotic Patients With Spontaneous Bacterial Peritonitis

Summary: spontaneous bacterial peritonitis (sbp) is a serious complication of ascites that can lead to death and can be described as an acute infection of ascites without any certain source of infection sbp is considered the most common infection in cirrhotic patients with ascites. sbp is diagnosed by the presence of ≥250 polymorphonuclear leukocyte (pmnl)/mm3 in the ascetic fluid in absence of surgical and treatable causes of intra-abdominal infections . sbp has many pictures of clinical presentation sbp can be asymptomatic and patients pass unnoticed or can discovered accidentally may have local symptoms and signs of peritonitis such as abdominal pain, and tachypnea or may present with signs of deteriorated liver function in form of gastrointestinal bleeding, shock and renal failure an increasing amount of studies have demonstrated that peripheral blood neutrophil-to-lymphocyte ratio (nlr), monocyte-to-lymphocyte ratio (mlr), platelet-to-lymphocyte ratio (plr) are indicators of systematic inflammatory response and are widely investigated as useful predictors of the clinical outcomes in various diseases .


Eligibility criteria:
inclusion criteria: * cirrhotic patient with ascites. * un treated sbp exclusion criteria: * ascites without cirrhosis (malignant ascites, chylous ascites, etc...). * tuberculous peritonitis. * secondary bacterial peritonitis due to any surgical cause. * sepsis rather than sbp. * patients with unrelated infections e.g. skin, chest infection, etc. * patients started treatment of sbp. * patients on prophylactic antibiotics for recurrent sbp prevention . * patients declining to provide informed consent. * patients with hepatocellular carcinoma on top of cirrhosis. * patients with other malignancy or any immunological disease
ultrasound guided needling versus ultrasound guided corticosteroid injection alone, a randomized controlled trial.

Conditions: Calcific Tendinitis

Summary: ultrasound guided needling is becoming an accepted treatment for patients with shoulder pain due to calcifying tendinitis. however, evidence for this treatment is lacking. the investigators expect that patients treated with us guided needling with corticosteroid injection compared with patients treated with only corticosteroid injections in the subacromial bursa have better clinical outcome after one year follow-up.

calcifying tendinitis of the shoulder is a common cause of shoulder pain with an incidence ranging from 2.7 % to 6.8 %. this disease of the rotator cuff tendons is characterised by calcifications in the tendons, most commonly in the supraspinatus tendon up to 82%. the aetiology remains unclear. calcifying tendinitis is regarded as a self-healing condition with usually spontaneous resolution of the calcifications. but some patients have chronic or recurrent pain and disability of the shoulder which requires treatment. the treatment should be minimally invasive and effective in short and long term. symptomatic treatment is indicated first using non-steroidal anti-inflammatory drugs, therapeutic exercise and non ultrasound guided subacromial corticosteroids injection. the role of corticosteroid injections is unknown due to the lack of good studies. family doctors and orthopaedic surgeons inject corticosteroids in the shoulder without the guidance of ultrasound; with this method accurate needle placement in the subacromial bursa is not possible. when this treatment fails other therapeutical methods can be used. ultrasound guided needling is a percutaneous technique of fragmentation or extraction of calcifications in the rotator cuff tendon. literature shows favourable results but only a few randomized controlled trials were executed. randomised controlled trials are needed to give more insight in the effectiveness of us guided needling. comparing two groups of patients treated with us guided corticosteroid injection and one group combined with us guided needling can provide information of the usefulness of us guided needling.

Eligibility criteria:
inclusion criteria: * shoulder pain without improvement after 3 months despite conservative treatment * calcification on x-ray (gartner type i of ii) and ultrasound in the supraspinatus tendon less than 6 weeks before the treatment * all patients are first seen and included by the orthopaedic surgeon exclusion criteria: * previous operation of the shoulder * previous ultrasound guided needling of the shoulder * frozen shoulder * last corticosteroid injection less than 3 months ago * comorbidities of the painful shoulder on x-ray or ultrasound ( ruptured tendon, fracture, bursitis,...) * no informed consent * pregnancy

Keywords: calcifying tendinitis rotator cuff
antimicrobial photodynamic therapy mediated by papain gel on peri-implantitis lesions

Conditions: Peri-Implantitis

Summary: the elimination of pathogenic microorganisms from the muco-gingival tissue and implant pockets system is one of the main aspects for success in the treatment of peri-implantitis. the purpose of this study is to conduct a blinded and randomized clinical trial to evaluate the effectiveness of photodynamic therapy in the treatment of peri-implantitis. twenty implants with peri-implantitis will be selected. implants will be randomly divided into two groups (n = 10), group 1: control - conventional treatment and group 2: conventional treatment and antimicrobial photodynamic therapy (apdt). apdt will be performed after the purse removal service in sites with pockets greater than or equal to 5 mm. the photosensitizer will be papamblue®, which will be deposited in the peri-implant pockets, with pre-irradiation time of 1 min. next, the laser emitting a wavelength of 660 nm, with power of 100 mw, for 2 min, radiant exposure of 30 j/cm2 and power density of 250 mw/cm2 in the buccal and mesial regions will be applied. the distribution of the data within each group will be evaluated and the variances will be checked to choose a more appropriate statistical analysis. the sample calculation is based on the literature and the significance level of 5% will be adopted.


Eligibility criteria:
inclusion criteria: * have peri-implantitis; * have at least one implant with a clinical depth of probing equal to or greater than 5 mm; * age range of 18 to 65 years. exclusion criteria: * smokers or ex-smokers who stopped the habit less than 12 months before the screening; * have decompensated diabetes; * anemia; * cancer; * pregnant; * use antibiotics in the last 3 months12; * make use of anti-inflammatories or have coagulation disorders (use of anticoagulants, presence of liver diseases, thrombocytopenia, immunosuppression); * in orthodontic treatment; * patients who maintained a biofilm index higher than 25%.
clinical and genetic profile of pediatric patients with cystic fibrosis in sohag.

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is an autosomal recessive genetic disorder caused by mutations in the gene encoding cf transmembrane conductance regulator (cftr), which is located at 7q31.2 and encodes 1480 amino acids. cftr protein is responsible for regulating the transport of electrolytes and chloride across epithelial and mucus-producing cell membranes.

the discovery of the cftr gene in the late 1980s triggered a surge of basic research that enhanced understanding of the pathophysiology and the genotype-phenotype relationships of this clinically variable disease of cystic fibrosis. more than 2000 variants of cftr gene have been reported, and they are grouped to six classes depending on the pathophysiology of the cftr protein ,the most common genetic defect reported in cf is the delta f508 mutation, moreover, the degree of cf severity depends on the type of mutation, which typically affects the function and quantity of cftr channels. when the cftr protein is mutated, chloride ions accumulate in mucus-producing cells, resulting in a thick, sticky mucus that obstructs various pathways and hinders pulmonary, digestive, exocrine and male reproductive functions. furthermore, mucus buildup increases a patient's susceptibility to airway obstruction, bacterial lung infection, pancreatic insufficiency, malabsorption and infertility. cf is characterized by significant clinical heterogeneity.

Eligibility criteria:
inclusion criteria: * children and adolescents aged 2 days - 18 year. * patients clinically suspected or diagnosed with cystic fibrosis * patients diagnosed with cystic fibrosis and attending or referred to the pediatric pulmonology clinic at sohag university hospital. exclusion criteria: * patient with cystic fibrosis like symptoms with another confirmed diagnosis ex. primary ciliary dyskinesia

Keywords: sweat chloride test genetics
aluminum and auditory function in esrd

Conditions: End-Stage Renal Disease (ESRD)

Summary: hearing impairment either clinical or subclinical is a characteristic of some renal disease patients. the hearing impairment could be result from specific etiologies or chronic renal failure itself. the causes of hearing impairment in renal disease patients ranged from drugs intoxication in both auditory and renal function, like gentamycin or isoniazid, congenital disease like alport syndrome or other collagen-defective renal disease, or just aging related. end-stage renal disease (esrd) patients are special in many parts to general population who have hearing impairment. first, inflammation in esrd patients is well-documented, second, they suffered from various underlying diseases which auditory function was potentially impaired, third, they need to undergo renal replacement therapy either hemodialysis (hd) or peritoneal dialysis (pd) to maintain their life. dialysis itself was found to be a cause of hearing impairment, too. the biochemical change and constitutive inflammation status are thought to be implicated in the pathogenesis of hearing impairment in esrd patients. aluminum (al) is a well-documented heavy metal, which predisposes to alzheimer's disease, dementia or some neurologic diseases. al intoxication is very rare in general health population but elevated serum al level is easily found in esrd patients since they can not excrete al by damaged kidneys and dialyzers. inner ear per se is a neurologic tissue, so if serum al level in esrd patients has any association in their haring function needs to be studied.


Eligibility criteria:
inclusion criteria: esrd patients and healthy volunteers, without history of occupational noise exposure, ear infection, ear surgery, active systemic infection, previous ototoxic drugs exposure or congenital hearing defect exclusion criteria: unsuitable to undergo hearing test, with history of occupational noise exposure, ear infection, ear surgery, active systemic infection, previous ototoxic drugs exposure or congenital hearing defect
comparative efficacy of novel transcranial random noise stimulation versus direct current stimulation on augmenting digital mirror therapy in chronic stroke

Conditions: Transcranial Direct Current Stimulation (tDCS); Transcranial Random Noise Stimulation (tRNS)

Summary: this study will be the first to investigate the effects of novel brain neurotechnology, which is the trns combined with digital mt. the investigators will perform a head-to-head comparison of the effects of the innovative trns- and tdcs-augmented digital mt interventions comprehensively on clinical, neurophysiological and motor control outcomes in stroke patients. the eeg and kinematic assessment will be used for assessing brain activities and upper extremity motor control. in addition, the investigators will identify the good responders to the trns- and tdcs-augmented digital mt interventions to determine the appropriate candidate for the innovative hybrid interventions. the overall findings of this research project will help advance current knowledge of brain neurotechnology and lead to development of neurophysiological and clinical evidence-based brain neurotechnology-augmented digital mt interventions for use in the clinical settings.


Eligibility criteria:
inclusion criteria: 1. 3 months onset from a first-ever unilateral stroke; 2. an initial fma scores between 18 to 56, indicating moderate to mild upper extremity motor impairment55; 3. age between 35 to 85; 4. no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist and fingers); 5. ability to follow instructions and perform tasks (mini mental state examination scores 24); 6. no participation in any neurorehabilitation experiments or drug clinical trials 7. willing to provide written informed consent exclusion criteria: 1. contradiction to trns and tdcs including a history of epilepsy, pregnant, having pacemakers and metallic implants in the neck and head ; 2. history of drug or alcohol abuse ; 3. concomitant neurological conditions such as dementia, parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema); 4. botulinum toxin injections 3 months before enrollment 5. have unstable cardiovascular status such as uncontrolled hypertension or new york heart association (nyha) class iii/iv heart failure or are not suitable for receiving trns by the physician's assessments.
linagliptin versus placebo in type 2 diabetic patients with inadequate glycaemic control on metformin in combination with pioglitazone

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Eligibility criteria:
inclusion criteria: 1. diagnosis of diabetes mellitus prior to informed consent 2. patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks) 3. glycosylated haemoglobin a1 \>= 7.5% and \<= 10% 4. age between 18 and less than 80 5. - body mass index less or equal to 45 exclusion criteria: 1. uncontrolled hyperglycaemia during run in period 2. myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent 3. impaired hepatic function 4. gastric by pass surgery 5. treatment with roziglitazone, glp 1 analogues, dpp-4 inhibitors or insulin within 3 months prior to informed consent 6. treatment with anti-obesity drugs 7. current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent 8. premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial